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Bethesda North Marriott Hotel and Conference Center

Apr 09, 2014 7:00 AM - Apr 10, 2014 5:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling 2014: Compliance in a Changing Regulatory Environment

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Session 9 - FDA Labeling Update

Session Chair(s)

Su-Yueh Lin

Su-Yueh Lin

Sr. Labeling Consultant, Regulatory Affairs

SYL Regulatory Consulting, Taiwan

This session will focus on recently published labeling guidances and provide an update on the Physician Labeling Rule (PLR). The following FDA labeling guidances will be discussed: 2013 Patient Counseling Information Section of Labeling (draft); 2013 Implementing the PLR Content and Format Requirements; 2013 Pediatric Information Incorporated into USPI (draft); 2012 Drug Interactions Studies: Labeling Recommendations (draft); and 2010 Dosage and Administration Section of Labeling.

Speaker(s)

Eric Brodsky, MD

Content and Format of the United States Prescribing Information (USPI) for Human Prescription Drug and Biological Products: Update on Labeling Guidances

Eric Brodsky, MD

FDA, United States

Associate Director, Labeling Development Team, Office of New Drugs, CDER

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